Emc Declaration - marsden UFR103 User Manual

EMC Declaration

IEC 60601-1-2: 2014 ME EQUIPMENT and ME SYSTEMS identification, marking and documents for
Class B product
Instructions for use
The ME EQUIPMENT or ME SYSTEM is suitable for home and healthcare environments.
Warning: Don't near active HF surgical equipment and the RF shielded room of an ME system for
magnetic resonance imaging, where the intensity of EM disturbances is high.
Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating normally.
Warning: Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation."
Warning: Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the infrared
thermometer, including cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
A list of all cables and maximum lengths of cables (if applicable), transducers and other
ACCESSORIES that are replaceable by the RESPONSIBLE ORGANISATION and that are likely to
affect compliance of the ME EQUIPMENT or ME SYSTEM with the requirements of Clause 7
(EMISSIONS) and Clause 8 (IMMUNITY). ACCESSORIES may be specified either generically (e.g.
shielded cable, load impedance) or specifically (e.g. by MANUFACTURER and EQUIPMENT OR
TYPE REFERENCE).
The performance of the ME EQUIPMENT or ME SYSTEM that was determined to be ESSENTIAL
PERFORMANCE and a description of what the OPERATOR can expect if the ESSENTIAL
PERFORMANCE is lost or degraded due to EM DISTURBANCES (the defined term "ESSENTIAL
PERFORMANCE" need not be used).
Technical description
1.All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with
regard to electromagnetic disturbances for the excepted service life.
2.Guidance and manufacturer's declaration -electromagnetic emissions and Immunity.
Table 1
Guidance and manufacturer's declaration - electromagnetic emissions
Emissions test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations/ flicker emissions
IEC 61000-3-3
Compliance
Group 1
Class B
N/A
N/A
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